Application 217563
- Type
- ANDA
- Sponsor
- MICRO LABS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | METOLAZONE | METOLAZONE | TABLET;ORAL | 2.5MG | No | No |
| 002 | METOLAZONE | METOLAZONE | TABLET;ORAL | 5MG | No | No |
| 003 | METOLAZONE | METOLAZONE | TABLET;ORAL | 10MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A217563-001 | METOLAZONE | METOLAZONE | 2.5MG | TABLET / ORAL | 2024-11-06 | ||
| A217563-002 | METOLAZONE | METOLAZONE | 5MG | TABLET / ORAL | 2024-11-06 | ||
| A217563-003 | METOLAZONE | METOLAZONE | 10MG | TABLET / ORAL | 2024-11-06 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A217563-001 | METOLAZONE | 2.5MG | TABLET / ORAL | 2024-11-06 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A217563-002 | METOLAZONE | 5MG | TABLET / ORAL | 2024-11-06 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A217563-003 | METOLAZONE | 10MG | TABLET / ORAL | 2024-11-06 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A217563-001 | METOLAZONE | 2.5MG | TABLET / ORAL | AB | 2024-11-06 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A217563-002 | METOLAZONE | 5MG | TABLET / ORAL | AB | 2024-11-06 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A217563-003 | METOLAZONE | 10MG | TABLET / ORAL | AB | 2024-11-06 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A217563-001 | METOLAZONE | 2.5MG | TABLET / ORAL | AB | 2024-11-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A217563-002 | METOLAZONE | 5MG | TABLET / ORAL | AB | 2024-11-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A217563-003 | METOLAZONE | 10MG | TABLET / ORAL | AB | 2024-11-06 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217563-001 | METOLAZONE | 2.5MG | TABLET / ORAL | AB | 2024-11-06 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217563-002 | METOLAZONE | 5MG | TABLET / ORAL | AB | 2024-11-06 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217563-003 | METOLAZONE | 10MG | TABLET / ORAL | AB | 2024-11-06 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A217563-001 | METOLAZONE | 2.5MG | TABLET / ORAL | AB | 2024-11-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A217563-002 | METOLAZONE | 5MG | TABLET / ORAL | AB | 2024-11-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A217563-003 | METOLAZONE | 10MG | TABLET / ORAL | AB | 2024-11-06 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217563-001 | METOLAZONE | 2.5MG | TABLET / ORAL | AB | 2024-11-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217563-002 | METOLAZONE | 5MG | TABLET / ORAL | AB | 2024-11-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217563-003 | METOLAZONE | 10MG | TABLET / ORAL | AB | 2024-11-06 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217563-001 | METOLAZONE | 2.5MG | TABLET / ORAL | AB | 2024-11-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217563-002 | METOLAZONE | 5MG | TABLET / ORAL | AB | 2024-11-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217563-003 | METOLAZONE | 10MG | TABLET / ORAL | AB | 2024-11-06 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217563-001 | METOLAZONE | 2.5MG | TABLET / ORAL | AB | 2024-11-06 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217563-002 | METOLAZONE | 5MG | TABLET / ORAL | AB | 2024-11-06 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217563-003 | METOLAZONE | 10MG | TABLET / ORAL | AB | 2024-11-06 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217563-001 | METOLAZONE | 2.5MG | TABLET / ORAL | AB | 2024-11-06 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217563-002 | METOLAZONE | 5MG | TABLET / ORAL | AB | 2024-11-06 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217563-003 | METOLAZONE | 10MG | TABLET / ORAL | AB | 2024-11-06 | 2680178bc6a6… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A217563-001 | METOLAZONE | 2.5MG | TABLET / ORAL | AB | 2024-11-06 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A217563-002 | METOLAZONE | 5MG | TABLET / ORAL | AB | 2024-11-06 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A217563-003 | METOLAZONE | 10MG | TABLET / ORAL | AB | 2024-11-06 | d8e5a09893c0… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217563-001 | METOLAZONE | 2.5MG | TABLET / ORAL | AB | 2024-11-06 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217563-002 | METOLAZONE | 5MG | TABLET / ORAL | AB | 2024-11-06 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217563-003 | METOLAZONE | 10MG | TABLET / ORAL | AB | 2024-11-06 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A217563-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A217563-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A217563-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A217563-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A217563-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A217563-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217563-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217563-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217563-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A217563-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A217563-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A217563-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217563-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217563-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217563-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217563-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217563-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217563-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217563-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217563-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217563-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217563-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217563-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217563-003 | AB | 1 | 2680178bc6a6… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A217563-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A217563-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A217563-003 | AB | 1 | d8e5a09893c0… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217563-001 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217563-002 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217563-003 | AB | 1 | a50c72e98297… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| METOLAZONE | METOLAZONE | Alembic Pharmaceuticals Limited | 0f189f26-be06-4030-aebc-d0557b6475fb | 2024-05-28 | Warnings, Adverse reactions | METOLAZONE METOLAZONE |
| Metolazone | METOLAZONE | Bryant Ranch Prepack | 564eccca-2eba-4b6d-b6ab-1439c4c83906 | 2024-05-23 | Warnings, Adverse reactions | Metolazone METOLAZONE |
| METOLAZONE | METOLAZONE | Alembic Pharmaceuticals Inc. | a84dbb37-648e-42d4-8688-ac39599284f0 | 2024-05-21 | Warnings, Adverse reactions | METOLAZONE METOLAZONE |
| METOLAZONE | METOLAZONE | A-S Medication Solutions | fc937c08-7bc0-4f97-80c9-e091e97f2f9a | 2023-12-27 | Warnings, Adverse reactions | METOLAZONE METOLAZONE |
| Metolazone | METOLAZONE | Bryant Ranch Prepack | 8f8a79d5-5404-46f1-9974-47ae05e855d7 | 2023-12-11 | Warnings, Adverse reactions | Metolazone METOLAZONE |
| Metolazone | METOLAZONE | A-S Medication Solutions | c9e51766-8f1d-4258-9f40-1d394e2de04c | 2023-11-13 | Warnings, Adverse reactions | Metolazone METOLAZONE |
| Metolazone | METOLAZONE | Bryant Ranch Prepack | 88c93278-7cf6-4f84-bc03-44bfb8b91e37 | 2023-11-01 | Warnings, Adverse reactions | Metolazone METOLAZONE |
| Metolazone | METOLAZONE | Mylan Pharmaceuticals Inc. | 6639d111-eb21-4997-b964-f5c61bc088f2 | 2019-10-01 | Warnings, Adverse reactions | Metolazone METOLAZONE |
| Metolazone | METOLAZONE | Aphena Pharma Solutions - Tennessee, LLC | 71f86ee1-9e43-482b-9ad8-ec5d5576f360 | 2019-06-03 | Warnings, Adverse reactions | Metolazone METOLAZONE |
| Metolazone | METOLAZONE | Aphena Pharma Solutions - Tennessee, LLC | 80500d09-e1c5-450a-9806-f4f13843229d | 2017-12-14 | Warnings, Adverse reactions | Metolazone METOLAZONE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.